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ULTRAtab Laboratories Recalls
43 recalls on record · January 12, 2022 to February 16, 2022 · Drugs, Food & Beverage
February 16, 2022DrugsFDA
ULTRAtab Laboratories, Inc. recalls Coated APAP 500 mg caplet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-206
Hazard: CGMP Deviations
February 16, 2022DrugsFDA
ULTRAtab Laboratories, Inc. recalls Normed APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-203-00
Hazard: CGMP Deviations
February 16, 2022DrugsFDA
ULTRAtab Laboratories, Inc. recalls Coated APAP 325mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-202-00
Hazard: CGMP Deviations
February 16, 2022DrugsFDA
ULTRAtab Laboratories, Inc. recalls APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-200-00
Hazard: CGMP Deviations
February 16, 2022DrugsFDA
ULTRAtab Laboratories, Inc. recalls APAP 500 mg Phenyl HCl 5mg tablet (Acetaminophen 500mg, Phenylephrine HCl 5mg), Bulk Container, ULTRAtab Laboratories, I
Hazard: CGMP Deviations
February 16, 2022DrugsFDA
ULTRAtab Laboratories, Inc. recalls APAP 325 mg/Phenylephrine HCl, 5mg Tablets Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-135-00
Hazard: CGMP Deviations
February 16, 2022DrugsFDA
ULTRAtab Laboratories, Inc. recalls Coated APAP 325 mg Phenyl HCl 5 mg tablet (Acetaminophen 325 mg, Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laborat
Hazard: CGMP Deviations
February 16, 2022DrugsFDA
ULTRAtab Laboratories, Inc. recalls Dologen 325 Caplet (Acetaminophen 325 mg, Dexbrompheniramine Maleate 1.0 mg) Bulk Container, ULTRAtab Laboratories, Inc.
Hazard: CGMP Deviations
February 16, 2022DrugsFDA
ULTRAtab Laboratories, Inc. recalls Kramer Novis Tusicof Caplet (Guaifenesin 400 mg, Dextromethorphan HBr 20 mg, Phenylephrine HCl 10 mg) Bulk Container, UL
Hazard: CGMP Deviations
February 16, 2022DrugsFDA
ULTRAtab Laboratories, Inc. recalls Zee Cold Tabs (Acetaminophen 325 mg, Guaifenesin 100 mg, Phenylephrine HCl 5 mg Bulk Container, ULTRAtab Laboratories, I
Hazard: CGMP Deviations
February 16, 2022DrugsFDA
ULTRAtab Laboratories, Inc. recalls 4-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Dextromethorphan HBr 15mg, Phenylephrine HCL 5mg) Bulk
Hazard: CGMP Deviations
February 16, 2022DrugsFDA
ULTRAtab Laboratories, Inc. recalls 3-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laborat
Hazard: CGMP Deviations
January 12, 2022DrugsFDA
ULTRAtab Laboratories, Inc. recalls PAIN AID ESF- (Acetaminopehn USP 250mg, Asprin USP 250mg Caffeine 65mg) coated, bulk OTC tablets packaged in corrugated
Hazard: CGMP Deviations: failed stability results, inadequate laboratory investigations,